WO2024090235A1 - Système d'aiguille - Google Patents

Système d'aiguille Download PDF

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Publication number
WO2024090235A1
WO2024090235A1 PCT/JP2023/037139 JP2023037139W WO2024090235A1 WO 2024090235 A1 WO2024090235 A1 WO 2024090235A1 JP 2023037139 W JP2023037139 W JP 2023037139W WO 2024090235 A1 WO2024090235 A1 WO 2024090235A1
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WO
WIPO (PCT)
Prior art keywords
needle
electrode
resin tube
organ
disposed
Prior art date
Application number
PCT/JP2023/037139
Other languages
English (en)
Japanese (ja)
Inventor
美穂 小林
雄起 向井
Original Assignee
株式会社カネカ
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 株式会社カネカ filed Critical 株式会社カネカ
Publication of WO2024090235A1 publication Critical patent/WO2024090235A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/46—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for controlling depth of insertion

Definitions

  • the present invention relates to a needle system having a needle for puncturing an internal organ.
  • Treatments such as direct administration of a medicinal solution such as a myocardial regenerative cell preparation to myocardial cells that are losing their function due to myocardial infarction are being carried out to regenerate myocardial cells.
  • a catheter with a needle When administering a medicinal solution directly to an internal organ, a catheter with a needle must be inserted into a body cavity and the needle must be punctured into the organ. If the needle does not puncture deep enough that the hole for administering the medicinal solution is not located within the organ, the medicinal solution cannot be administered to the organ. For this reason, there has been a demand for the development of a needle that can determine whether the needle has been inserted until the hole for administering the medicinal solution is located within the organ, and that can reliably administer the medicinal solution to the organ.
  • Patent Document 1 describes a drug injection needle that is a hollow needle for injecting a drug solution by puncturing the myocardium of a patient, and includes a sharp metal tip member, an electrically insulating connecting tube connected to the base end of the tip member, a metal tube connected to the base end of the connecting tube, and an insulating layer that covers the outer surface of the base end of the metal tube, and the connecting tube and/or tip member have at least one hole (a drug solution outflow path) that communicates with the lumen of the needle and opens on the outer surface of the connecting tube or tip member, and the tip portion of the metal tube that is not covered by the insulating layer constitutes an electrode for measuring electric potential.
  • a drug injection needle that is a hollow needle for injecting a drug solution by puncturing the myocardium of a patient, and includes a sharp metal tip member, an electrically insulating connecting tube connected to the base end of the tip member, a metal tube connected to the base end of the connecting tube, and an insulating layer that covers the outer surface
  • This drug injection needle can easily determine whether the opening for drug solution injection is located inside the heart wall by checking whether the electric potential measured by the electrode is equal to or greater than a predetermined value, and by confirming that the electric potential is equal to or greater than a predetermined value and performing the drug solution injection operation, the drug solution can be reliably injected into the myocardium from the opening of the hole.
  • Patent Document 2 describes a drug injection needle system that includes a sharp metal tip member, an electrically insulating connecting tube connected to the base end side of the tip member, a metal tube connected to the base end side of the connecting tube, and an insulating layer covering the outer surface of the base end portion of the metal tube, and the connecting tube and/or tip member have at least one hole that communicates with the lumen of the needle and opens to the outer surface of the connecting tube or tip member, and the tip portion of the metal tube that is not covered by the insulating layer constitutes an electrode for measuring potential, and includes a notification means that notifies the operator that the drug solution can be injected into the myocardium when the first potential measured by the tip electrode is equal to or greater than a first threshold and the second potential measured by the electrode of the drug injection needle is equal to or greater than a second threshold.
  • This drug injection needle system can reliably inject the drug solution into the patient's myocardium by waiting for a notification from the notification means when the first potential measured by the tip electrode of the electrode catheter becomes equal to or greater than the first threshold and the second potential measured by the electrode of the drug injection needle becomes equal to or greater than the second threshold, and then performs the drug solution injection operation.
  • Patent Document 3 describes a drug injection needle that is a hollow needle for injecting a drug solution by puncturing the myocardium of a patient, and includes a first electrode for measuring potential made of a sharp metal member with a closed tip, an electrically insulating connecting tube connected to the base end of the first electrode, a metal tube connected to the base end of the connecting tube, and an insulating coating layer that covers the outer surface of the base end portion of the metal tube.
  • At least one side hole (outflow path for drug solution) that communicates with the inner cavity of the needle (the inner cavity of the connecting tube) and opens onto the outer surface of the connecting tube is formed in the tube wall, and the tip portion of the metal tube that is not covered by the insulating coating layer constitutes a second electrode for measuring potential.
  • this drug injection needle can determine that the opening of the side hole formed in the tube wall of the connecting tube is located in the myocardium, and by performing the drug injection operation after confirming that both potentials are equal to or greater than a predetermined value, the drug solution can be reliably injected into the myocardium from the opening of the side hole.
  • the present invention was made in consideration of the above circumstances, and its purpose is to provide a needle system that can grasp the depth to which a needle has been inserted into an internal organ.
  • a resin tube having an inner lumen extending in a longitudinal direction; a needle made of a conductive material, disposed in an inner cavity of the resin tube so as to be movable in the longitudinal direction relative to the resin tube, and inserted into an organ in the body; A first electrode disposed on an outer surface of the resin tube; and a meter that measures the electrical resistance between the needle and the first electrode when a current is passed between the needle and the first electrode.
  • the needle is transported to the organ to be treated while being placed in the lumen of the plastic tube. After transport, the distal end of the plastic tube is brought into contact with the organ, and while a current is passed between the needle and the first electrode, the needle is moved distally relative to the plastic tube, and the needle is protruded from the distal end of the plastic tube to puncture the organ.
  • a current between the needle and the first electrode while the distal end of the plastic tube is brought into contact with the organ, the current flowing between the needle and the first electrode flows through the organ. Therefore, the electrical resistance between the needle and the first electrode decreases the moment the needle is punctured into the organ.
  • the deeper the needle is punctured into the organ the larger the contact area between the needle and the organ that serves as the electrical flow path, and therefore the lower the electrical resistance between the needle and the first electrode. Therefore, by measuring the electrical resistance between the needle and the first electrode when a current is passed between the needle and the first electrode, the depth to which the needle has punctured the organ can be determined from the change in value.
  • the needle system according to the embodiment of the present invention is preferably any one of the following [2] to [11].
  • [2] The needle system described in [1], wherein the first electrode is annular and is positioned at the distal portion of the resin tube.
  • a second electrode is disposed on an outer surface of the resin tube and is located proximal to the first electrode, The needle system of claim 1 or 2, wherein the measuring device is configured to measure the electrical resistance between the needle and the second electrode when a current is passed between the needle and the second electrode.
  • the needle system described in [3] wherein there is a gap between the first electrode and the second electrode in the longitudinal direction that is at least the length of one first electrode or one second electrode.
  • the needle has a sidewall that defines a lumen of the needle;
  • the hole is formed in a plurality of holes in the side wall of the needle, The needle system according to claim 7, wherein the plurality of holes are aligned in the longitudinal direction.
  • a second insulating substrate is disposed on the outer surface of the needle proximal to the proximal end of the first insulating substrate.
  • the needle system of the present invention measures the electrical resistance between the needle and the first electrode when a current is passed between the needle and the first electrode, and from the change in this resistance it is possible to determine the depth to which the needle has been inserted into an internal organ.
  • FIG. 1 is a side view showing an example of a needle system according to an embodiment of the present invention.
  • FIG. 2 depicts a cross-sectional view (partial side view) of the needle system shown in FIG.
  • FIG. 3 shows an enlarged cross-sectional view of the distal portion of the resin tube and needle in the needle system shown in FIG.
  • FIG. 4 is a cross-sectional end view taken along line IV-IV shown in FIG.
  • FIG. 5 shows an enlarged cross-sectional view of the distal portion of the resin tube and needle in the needle system shown in FIG.
  • FIG. 6 is a side view (partially in cross section) showing a modification of the resin tube and needle shown in FIG.
  • FIG. 7 shows a cross-sectional view of the resin tube and needle shown in FIG. FIG.
  • FIG. 8 is a cross-sectional end view taken along line VIII-VIII shown in FIG.
  • FIG. 9 is a side view (partially in cross section) showing another modified example of the resin tube and needle shown in FIG.
  • FIG. 10 shows a cross-sectional view of the resin tube and needle shown in FIG.
  • FIG. 11 is a cross-sectional end view taken along line XI-XI shown in FIG.
  • FIG. 12 is a cross-sectional end view taken along line XII-XII shown in FIG.
  • FIG. 13 is a side view (partially in cross section) showing another modified example of the resin tube and needle shown in FIG.
  • FIG. 14 shows a cross-sectional view of the resin tube and needle shown in FIG.
  • FIG. 10 shows a cross-sectional view of the resin tube and needle shown in FIG.
  • FIG. 11 is a cross-sectional end view taken along line XI-XI shown in FIG.
  • FIG. 12 is a cross-sectional end view taken
  • FIG. 15 is a cross-sectional end view taken along line XV-XV shown in FIG.
  • FIG. 16 is a cross-sectional end view taken along line XIV-XIV shown in FIG.
  • FIG. 17 is a side view showing a modified example of a needle system according to an embodiment of the present invention.
  • FIG. 18 depicts a cross-sectional view (partially a side view) of the needle system shown in FIG.
  • One embodiment of the needle system of the present invention has a resin tube having a lumen extending in the longitudinal direction, a needle made of a conductive material and arranged in the lumen of the resin tube so as to be movable in the longitudinal direction of the resin tube relative to the resin tube, for puncturing an organ in the body, a first electrode arranged on the outer surface of the resin tube, and a measuring device for measuring the electrical resistance between the needle and the first electrode when a current is passed between the needle and the first electrode.
  • FIGS. 1 and 2 show a needle system 1 having a resin tube 10, a needle 20, a first electrode 31, and a measuring device 40.
  • the longitudinal direction of the resin tube 10 is indicated by x
  • the radial direction is indicated by y.
  • the radial direction y is perpendicular to the longitudinal direction x.
  • the longitudinal direction x of the resin tube 10 is the extension direction of the resin tube 10.
  • the proximal side refers to the side closest to the user in the extension direction of the resin tube 10
  • the distal side refers to the opposite side of the proximal side, i.e., the side to be treated.
  • the distal portion of each component refers to the distal half of each component
  • the proximal portion of each component refers to the proximal half of each component.
  • FIG. 1 shows a side view of an example of a needle system according to an embodiment of the present invention.
  • FIG. 2 shows a cross-sectional view (partial side view) of the needle system shown in FIG. 1.
  • FIG. 3 shows an enlarged cross-sectional view of the distal portion of the plastic tube and needle in the needle system shown in FIG. 1.
  • FIG. 4 shows an end view of the cut portion taken along line IV-IV shown in FIG. 3.
  • FIG. 5 shows an enlarged cross-sectional view of the distal portion of the plastic tube and needle in the needle system shown in FIG. 2.
  • the needle system 1 has a plastic tube 10.
  • the plastic tube 10 has an inner lumen 11 extending in a longitudinal direction x.
  • the plastic tube 10 may have a distal end 10a and a proximal end 10b.
  • the plastic tube 10 preferably has an outer surface 14 facing the outside of the plastic tube 10 and an inner surface 15 facing the inner lumen 11.
  • the needle system 1 has a needle 20.
  • the needle 20 is disposed in the inner cavity 11 of the resin tube 10 so as to be movable in the longitudinal direction x of the resin tube 10 relative to the resin tube 10, and is intended to be inserted into an internal organ.
  • An internal organ refers to an organ located inside the body, particularly in the abdominal or thoracic region, and is also called an internal organ.
  • the needle 20 is also made of a conductive material. Thus, it functions as an electrode.
  • the entire needle 20 may be made of a conductive material, or only a portion of the needle 20 may be made of a conductive material.
  • the needle system 1 has a first electrode 31.
  • the first electrode 31 is made of a conductive material and is disposed on the outer surface 14 of the resin tube 10.
  • the needle system 1 has a measuring device 40.
  • the measuring device 40 measures the electrical resistance between the needle 20 and the first electrode 31 when a current is passed between the needle 20 and the first electrode 31.
  • the needle 20 is transported to the organ to be treated while being placed in the lumen 11 of the resin tube 10.
  • the distal end of the resin tube 10 is brought into contact with the organ, and the position of the needle 20 relative to the resin tube 10 is moved distally while a current is passed between the needle 20 and the first electrode 31, and the needle 20 is protruded from the distal end of the resin tube 10 to puncture the organ.
  • Figure 5 shows the state in which the needle 20 is protruding from the distal end of the resin tube 10.
  • the electrical resistance between the needle 20 and the first electrode 31 decreases the moment the needle 20 is punctured into the organ.
  • the deeper the needle 20 is inserted into the organ the larger the contact area between the needle 20 and the organ, which serves as a flow path for electricity, and the lower the electrical resistance between the needle 20 and the first electrode 31. Therefore, by measuring the electrical resistance between the needle 20 and the first electrode 31 when a current flows between the needle 20 and the first electrode 31, the depth to which the needle 20 has been inserted into the organ can be determined from the change in value.
  • the needle system 1 can be used to directly administer liquids such as cell preparations and medicinal solutions to internal organs, such as the heart, kidneys, and liver. Specifically, it can be used to directly administer an iPS cell suspension to the liver or kidneys, or to directly administer a myocardial regenerative cell preparation to the heart, or more specifically, the myocardium.
  • the resin tube 10 can be manufactured, for example, by extrusion molding.
  • the resin tube 10 can be composed of a single layer or multiple layers.
  • a portion of the resin tube 10 in the longitudinal direction x or circumferential direction may be composed of a single layer, and the other portion may be composed of multiple layers.
  • the resin tube 10 is preferably tubular in shape, but can be shaped like a hollow cylinder, hollow polygonal column, etc.
  • the resin tube 10 can be made of synthetic resins such as polyolefin resins (e.g., polyethylene and polypropylene), polyamide resins (e.g., nylon), polyester resins (e.g., PET), aromatic polyether ketone resins (e.g., PEEK), polyether polyamide resins, polyurethane resins, polyimide resins, and fluororesins (e.g., PTFE, PFA, ETFE). These may be used alone or in combination of two or more types.
  • synthetic resins such as polyolefin resins (e.g., polyethylene and polypropylene), polyamide resins (e.g., nylon), polyester resins (e.g., PET), aromatic polyether ketone resins (e.g., PEEK), polyether polyamide resins, polyurethane resins, polyimide resins, and fluororesins (e.g., PTFE, PFA, ETFE). These may be used alone or in combination of two or more
  • the resin tube 10 can be configured so that a first handle 51 that is held by the user is connected to the proximal portion of the resin tube 10.
  • the resin tube 10 may have a distal opening 12 and a proximal opening 13 that communicate with the lumen 11.
  • the distal end of the resin tube 10 be brought into contact with the organ so that the distal opening 12 of the resin tube 10 is blocked by the organ.
  • the needle 20 can be inserted into an internal organ, such as the heart, kidney, liver, etc.
  • a second handle 52 can be connected to the proximal portion of the needle 20 for manipulating the position of the needle 20 in the lumen 11 of the resin tube 10.
  • the proximal end of the needle 20 is preferably located proximal to the proximal end 10b of the resin tube 10. This makes it easier to manipulate the position of the needle 20 in the lumen 11 of the resin tube 10.
  • the length of the needle 20 is longer than the length of the resin tube 10 in the longitudinal direction x of the resin tube 10. This makes it easier to transmit torque, which is a rotational direction, in addition to the forward and backward push-pull directions to the needle 20, i.e., motion in three-dimensional directions, making it easier to manipulate the position of the needle 20 in the lumen 11 of the resin tube 10 and to make the needle 20 protrude from the distal end of the resin tube 10. This makes it easier to insert the needle 20 into an organ inside the body.
  • Needle 20 can be made of metal. Needle 20 may be entirely made of metal. Needle 20 may be only partially made of metal, with the other parts being made of a material other than metal, such as conductive resin.
  • metals that make up the needle 20 include stainless steels such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, Ni-Ti alloys, Co-Cr alloys, or combinations of these.
  • the needle 20 may have a portion made of a material having a higher electrical resistance than the tissue to be punctured by the needle 20. Only a portion of the needle 20 may be made of a material having a higher electrical resistance than the tissue to be punctured by the needle 20. This reduces the amount of electricity flowing in the portion made of a material having a higher electrical resistance than the tissue to be punctured. This makes it easier to see the reduction in electrical resistance when the needle 20 punctures an organ. This makes it easier to capture the change in electrical resistance, and makes it easier to grasp the depth to which the needle 20 has punctured the organ.
  • the entire needle 20 may be made of a material having a higher electrical resistance than the tissue to be punctured by the needle 20. This makes it easier to increase the change in electrical resistance before and after puncturing the organ, making it easier to grasp that the needle 20 has punctured the organ.
  • the needle 20 is preferably tubular in shape.
  • it can be hollow cylindrical, hollow polygonal prism, etc.
  • the needle 20 may have a lumen 21 extending in the longitudinal direction x of the resin tube 10.
  • the needle 20 may have an outer surface 25 located on the resin tube 10 side and an inner surface 26 facing the lumen 21 of the needle 20. This allows liquids such as cell preparations and medicinal fluids to be injected into the lumen 21 of the needle 20.
  • the needle system 1 may further include a liquid supplier 54 connected to the second handle 52.
  • the liquid supplier 54 is configured to be able to supply liquid such as a cell preparation or a drug solution to the inner cavity 21 of the needle 20.
  • the second handle 52 has an inner cavity, and the inner cavity of the second handle 52 and the inner cavity 21 of the needle 20 are connected, so that liquid such as a cell preparation or a drug solution supplied from the liquid supplier 54 can be supplied to the inner cavity 21 of the needle 20 via the inner cavity of the second handle 52.
  • the proximal end of the needle 20 may be directly connected to the liquid supplier 54, thereby supplying liquid such as a cell preparation or a drug solution to the inner cavity 21 of the needle 20.
  • the liquid supplier 54 may be any known means for supplying liquid, such as a syringe or a pump.
  • the distal end of the needle 20 may have an opening 22 that communicates with the inner cavity 21 of the needle 20.
  • the opening 22 provided at the distal end of the needle 20 refers to an opening portion that is visible when observed from the longitudinal direction x of the resin tube 10.
  • the opening 22 is preferably formed on the distal end surface of the needle 20.
  • the distal end surface of the needle 20 may be inclined with respect to the longitudinal direction x and radial direction y of the resin tube 10, and the opening 22 may be provided at the inclined portion. This allows liquid such as a cell preparation or a drug solution injected into the inner cavity 21 of the needle 20 to be discharged from the opening 22 provided at the distal end of the needle 20.
  • FIG. 6 shows a side view (partial cross-sectional view) of a modified resin tube and needle shown in FIG. 5.
  • FIG. 7 shows a cross-sectional view of the resin tube and needle shown in FIG. 6.
  • FIG. 8 shows an end view of the cut portion taken along line VIII-VIII shown in FIG. 6.
  • FIG. 9 shows a side view (partial cross-sectional view) of another modified resin tube and needle shown in FIG. 5.
  • FIG. 10 shows a cross-sectional view of the resin tube and needle shown in FIG. 9.
  • FIG. 11 shows an end view of the cut portion taken along line XI-XI shown in FIG. 9.
  • FIG. 12 shows an end view of the cut portion taken along line XII-XII shown in FIG. 9.
  • FIG. 9 shows a side view (partial cross-sectional view) of a modified resin tube and needle shown in FIG. 5.
  • FIG. 7 shows a cross-sectional view of the resin tube and needle shown in FIG. 6.
  • FIG. 8 shows an end
  • FIG. 13 shows a side view (partial cross-sectional view) of another modified resin tube and needle shown in FIG. 5.
  • FIG. 14 shows a cross-sectional view of the resin tube and needle shown in FIG. 13.
  • FIG. 15 shows an end view of the cut portion taken along line XV-XV shown in FIG. 13.
  • FIG. 16 shows an end view of the cut portion taken along line XIV-XIV shown in FIG. 3.
  • the needle 20 has a side wall 23 that forms the inner cavity 21 of the needle 20, and a hole 24 that communicates with the inner cavity 21 of the needle 20 may be formed in the distal part of the needle 20 and in the side wall 23 of the needle 20.
  • the hole 24 formed in the side wall 23 of the needle 20 refers to a hole that is visible when observed from the radial direction y of the resin tube 10.
  • the number of holes 24 formed in the needle 20 is not particularly limited, but for example, only one hole 24 may be formed as shown in Figures 6 to 8, or multiple holes 24 may be formed as shown in Figures 9 to 15.
  • the shape of the hole 24 formed in the needle 20 is not particularly limited, but can be, for example, circular, elliptical, polygonal, etc. From the standpoint of ease of forming the hole 24, a circular shape is preferable.
  • multiple holes 24 are formed in the side wall 23 of the needle 20, and the multiple holes 24 may be aligned in the longitudinal direction x of the resin tube 10. All of the multiple holes 24 may be aligned in the longitudinal direction x of the resin tube 10.
  • the flow path of electricity becomes narrower in the part where the holes 24 are formed, so the amount of electricity flowing decreases. Therefore, the decrease in electrical resistance when the needle 20 punctures an organ is more likely to appear. This makes it easier to capture changes in electrical resistance, making it easier to grasp the depth to which the needle 20 has punctured the organ.
  • liquids such as cell preparations and medicinal liquids injected into the lumen 21 of the needle 20 can be discharged from the multiple holes 24, allowing efficient injection of liquids such as cell preparations and medicinal liquids.
  • the needle 20 may have only an opening 22 formed at the distal end, and may not have a hole 24 formed in the side wall 23. Although not shown, the needle 20 may have only a hole 24 formed in the side wall 23, and may not have an opening 22 formed at the distal end. As shown in Figures 6 to 15, the needle 20 may have both an opening 22 formed at the distal end of the needle 20 and a hole 24 formed in the side wall 23 of the needle 20.
  • a first insulating substrate 71 may be disposed on the outer surface 25 of the needle 20, including the distal end of the needle 20.
  • the contact area between the needle 20 and the organ does not increase in the area where the first insulating substrate 71 is disposed, and therefore the number of paths through which electricity flows does not increase. Therefore, the amount of electricity flowing remains constant while only the area where the first insulating substrate 71 is disposed is punctured. This makes it easier to recognize the decrease in electrical resistance when the needle 20 is inserted into the area where the first insulating substrate 71 is not disposed. This makes it easier to grasp the change in electrical resistance value and to grasp the depth to which the needle 20 has been inserted into the organ.
  • a second insulating substrate 72 may be disposed on the outer surface 25 of the needle 20 proximal to the proximal end of the first insulating substrate 71.
  • the first insulating substrate 71 and the second insulating substrate 72 are materials that do not easily conduct electricity.
  • the first insulating substrate 71 and the second insulating substrate 72 are preferably made of resin.
  • the resin that constitutes the first insulating substrate 71 and the second insulating substrate 72 include polyimide resin, polyamide resin, polyolefin resin, polyester resin, polycarbonate resin, and epoxy resin.
  • the first insulating substrate 71 and the second insulating substrate 72 may be made of the same resin or different resins.
  • multiple second insulating substrates 72 may be arranged on the outer surface 25 of the needle 20. Although not shown, only one second insulating substrate 72 may be arranged on the outer surface 25 of the needle 20.
  • the first insulating substrate 71 is disposed on only a portion of the outer surface 25 of the needle 20, and is configured so that the first insulating substrate 71 does not cover the entire outer surface 25 of the needle 20.
  • the second insulating substrate 72 is disposed on only a portion of the outer surface 25 of the needle 20, and is configured so that the second insulating substrate 72 does not cover the entire outer surface 25 of the needle 20.
  • the first insulating substrate 71 and the second insulating substrate 72 are disposed on only a portion of the outer surface 25 of the needle 20, and are configured so that the first insulating substrate 71 and the second insulating substrate 72 do not cover the entire outer surface 25 of the needle 20.
  • the first insulating substrate 71 and the second insulating substrate 72 are preferably formed in a cylindrical shape, and the needle 20 is preferably disposed within the inner cavity of the cylindrical first insulating substrate 71 and the second insulating substrate 72.
  • a hole 24 when a hole 24 is formed in the portion of the needle 20 where the first insulating substrate 71 or the second insulating substrate 72 is disposed, it is preferable that a hole 74 communicating with the hole 24 of the needle 20 is formed in the first insulating substrate 71 or the second insulating substrate 72.
  • a hole 24 may be formed in a portion of the needle 20 where the first insulating substrate 71 and the second insulating substrate 72 are not disposed.
  • holes 24 may be formed in needles 20 where the first insulating substrate 71 and the second insulating substrate 72 are not disposed.
  • the first electrode 31 is preferably annular or cylindrical.
  • the first electrode 31 is preferably disposed in the distal portion of the resin tube 10, and more preferably disposed in the distal portion of the resin tube 10 proximal to the distal end of the resin tube 10.
  • the first electrode 31 is preferably connected to a measuring device 40, which will be described later.
  • the first electrode 31 does not have to be connected to a display device 41, which will be described later.
  • the measuring device 40 is not particularly limited as long as it can measure the electrical resistance between the needle 20 and the first electrode 31, and any known measuring device can be used. It is preferable that the measuring device 40 is connected to the needle 20 and the first electrode 31.
  • the needle system 1 may have a second electrode 32 disposed on the outer surface 14 of the resin tube 10 and located proximal to the first electrode 31.
  • the needle system 1 may have a third electrode 33 disposed on the outer surface 14 of the resin tube 10 and located proximal to the second electrode 32.
  • the needle system 1 may have a fourth electrode 34 disposed on the outer surface 14 of the resin tube 10 and located proximal to the third electrode 33. It is preferable that the second electrode 32, the third electrode 33, and the fourth electrode 34 are all disposed in the distal portion of the resin tube 10.
  • the needle system 1 is preferably configured to have a second electrode 32 disposed on the outer surface 14 of the resin tube 10 and located proximally of the first electrode 31, and to measure the electrical resistance between the needle 20 and the second electrode 32 when the measuring device 40 passes a current between the needle 20 and the second electrode 32.
  • the second electrode 32 is preferably connected to the measuring device 40.
  • the depth of the needle 20 punctured into the organ can be determined from the change in value.
  • This embodiment can be used preferably, for example, when the first electrode 31 is in contact with the myocardium and the second electrode 32 is not in contact with the myocardium. Even when the first electrode 31 is in contact with the myocardium, it is possible to measure the electrical resistance.
  • the electrical resistance of the myocardium is higher than that of blood, when the electrode is not in contact with the myocardium, the difference in electrical resistance when the needle 20 is in the blood and punctured into the myocardium is larger than when the electrode is in contact with the myocardium, making it easier to determine that the needle 20 has punctured the myocardium. In this way, it is easier to improve the measurement accuracy when the electrode is not in contact with the myocardium at all, i.e., when the entire electrode is in contact with the blood, than when the electrode is in contact with the myocardium.
  • the needle system 1 is preferably configured to have a third electrode 33 disposed on the outer surface 14 of the resin tube 10 and located proximally of the second electrode 32, and to measure the electrical resistance between the needle 20 and the third electrode 33 when the measuring device 40 passes a current between the needle 20 and the third electrode 33.
  • the third electrode 33 is preferably connected to the measuring device 40.
  • the depth of the needle 20 punctured into the organ can be determined from the change in value.
  • This embodiment can be used preferably, for example, when the first electrode 31 and the second electrode 32 are in contact with the myocardium and the third electrode 33 is not in contact with the myocardium. Even when the first electrode 31 and the second electrode 32 are in contact with the myocardium, it is possible to measure the electrical resistance.
  • the difference in electrical resistance when the needle 20 is in the blood and punctured into the myocardium is larger when the electrode is not in contact with the myocardium than when the electrode is in contact with the myocardium, making it easier to determine that the needle 20 has punctured the myocardium. In this way, it is easier to improve the measurement accuracy when the electrode is not in contact with the myocardium at all, i.e., when the entire electrode is in contact with the blood, than when the electrode is in contact with the myocardium.
  • the needle system 1 is preferably configured to have a fourth electrode 34 disposed on the outer surface 14 of the resin tube 10 and located proximal to the third electrode 33, and to measure the electrical resistance between the needle 20 and the fourth electrode 34 when the measuring device 40 passes a current between the needle 20 and the fourth electrode 34.
  • the fourth electrode 34 is preferably connected to the measuring device 40.
  • the depth of the needle 20 punctured into the organ can be determined from the change in value.
  • This embodiment can be used preferably, for example, when the first electrode 31, the second electrode 32, and the third electrode 33 are in contact with the myocardium, and the fourth electrode 34 is not in contact with the myocardium.
  • the first electrode 31, the second electrode 32, and the third electrode 33 are in contact with the myocardium, it is possible to measure the electrical resistance.
  • the difference in electrical resistance when the needle 20 is in the blood and punctured into the myocardium is larger when the electrode is not in contact with the myocardium than when the electrode is in contact with the myocardium, making it easier to determine that the needle 20 has punctured the myocardium. In this way, it is easier to improve the measurement accuracy when the electrode is not in contact with the myocardium at all, i.e., when the entire electrode is in contact with the blood, than when the electrode is in contact with the myocardium.
  • FIG. 17 shows a side view of a modified needle system according to an embodiment of the present invention.
  • FIG. 18 shows a cross-sectional view (partial side view) of the needle system shown in FIG. 17.
  • the second electrode 32 provided in the needle system 1 may be used to capture electrical signals from an organ.
  • the needle system 1 may have a display device 41 that is connected to the second electrode 32 and displays the electrical signals captured by the second electrode 32.
  • the second electrode 32 may be connected only to the display device 41, or may be connected to both the display device 41 and the measuring device 40.
  • the third electrode 33 provided in the needle system 1 may be used to capture electrical signals from an organ. In this case, as shown in Figs. 17 and 18, it is preferable that the third electrode 33 is connected to the display device 41.
  • the third electrode 33 may be connected only to the display device 41, or may be connected to both the display device 41 and the measuring device 40.
  • the fourth electrode 34 provided in the needle system 1 may be used to capture electrical signals from an organ. In this case, as shown in Figs. 17 and 18, it is preferable that the fourth electrode 34 is connected to the display device 41.
  • the fourth electrode 34 may be connected only to the display device 41, or may be connected to both the display device 41 and the measuring device 40.
  • the second electrode 32, the third electrode 33, and the fourth electrode 34 it is preferable to use electrodes that can detect electrical signals from the organ and detect the current that is being passed. For example, it is preferable to use electrodes that can detect the strength of the current, the direction in which the current flows, etc.
  • the electrical signal includes information such as the current, voltage, and potential.
  • the second electrode 32, the third electrode 33, and the fourth electrode 34 are preferably annular or cylindrical and positioned at the distal portion of the resin tube 10.
  • the first electrode 31 and the second electrode 32 are preferably formed in a cylindrical shape, and the resin tube 10 is preferably arranged in the inner cavity of the cylindrically formed first electrode 31 and second electrode 32.
  • the shape of the first electrode 31 and the shape of the second electrode 32 may be the same or different.
  • the third electrode 33 is also preferably formed in a cylindrical shape, and the resin tube 10 is preferably arranged in the inner cavity of the cylindrically formed third electrode 33.
  • the fourth electrode 34 is also preferably formed in a cylindrical shape, and the resin tube 10 is preferably arranged in the inner cavity of the cylindrically formed fourth electrode 34.
  • the first electrode 31, the second electrode 32, the third electrode 33, and the fourth electrode 34 can be made of a conductive material such as platinum or stainless steel, but it is preferable that they contain an X-ray opaque material such as platinum in order to make it easier to grasp the position of the electrodes under X-ray fluoroscopy.
  • the material constituting the first electrode 31, the material constituting the second electrode 32, the material constituting the third electrode 33, and the material constituting the fourth electrode 34 may be the same or different.
  • the display device 41 refers to a device capable of displaying an electrical signal captured by at least one of the second electrode 32, the third electrode 33, and the fourth electrode 34.
  • the display device 41 is preferably a device having a monitor unit that displays the electrical signal.
  • the strength of the current captured by at least one of the second electrode 32, the third electrode 33, and the fourth electrode 34 in the heart and the direction of the current flow are displayed by arrows or colors on the monitor unit of the display device 41.
  • the technology for displaying electrical signals on the display device 41 is generally called 3D mapping. With the above configuration, the user can easily grasp the treatment area causing the arrhythmia and the area that is losing function, making it easier to determine the puncture point of the needle 20.
  • first electrode 31 and the second electrode 32 there is a gap between the first electrode 31 and the second electrode 32 that is at least the length of one first electrode 31 or one second electrode 32 in the longitudinal direction x of the resin tube 10.
  • the needle system 1 may further include a power supply 53 that supplies a current to pass a current between the needle 20 and the first electrode 31.
  • the power supply 53 may pass a current between the needle 20 and the second electrode 32.
  • the third electrode 33 and the meter 40 are connected, the power supply 53 may pass a current between the needle 20 and the third electrode 33.
  • the fourth electrode 34 and the meter 40 are connected, the power supply 53 may pass a current between the needle 20 and the fourth electrode 34.
  • the needle 20 can be connected to a first conductor 61, which can be connected to a power supply 53.
  • the power supply 53 can be connected to a second conductor 62, which can be connected to a measuring device 40.
  • the first electrode 31 can be connected to a third conductor 63, which can be connected to a measuring device 40.
  • a plurality of third conductors 63 can be provided, and the second electrode 32, the third electrode 33, and the fourth electrode 34 can be connected to independent third conductors 63 different from the third conductor 63 to which the first electrode 31 is connected, and each of the third conductors 63 can be connected to the measuring device 40.
  • one electrode is connected to the measuring device 40 via an independent conductor.
  • a plurality of fourth conductors 64 may be provided, and the second electrode 32, the third electrode 33, and the fourth electrode 34 may each be connected to an independent fourth conductor 64, and each fourth conductor 64 may be connected to the display device 41.
  • one electrode is connected to the display device 41 via one independent conductor.
  • Needle system 10 Plastic tube 11: Plastic tube lumen 12: Distal opening 13: Proximal opening 14: Plastic tube outer surface 15: Plastic tube inner surface 20: Needle 21: Needle lumen 22: Opening 23: Side wall 24: Hole 25: Needle outer surface 26: Needle inner surface 31: First electrode 32: Second electrode 33: Third electrode 34: Fourth electrode 40: Meter 41: Display device 51: First handle 52: Second handle 53: Power supply device 54: Fluid supply device 61: First conductor 62: Second conductor 63: Third conductor 64: Fourth conductor 71: First insulating substrate 72: Second insulating substrate 74: Hole

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Vascular Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Un système d'aiguille (1) comprend : un tube en résine (10) ayant une cavité interne (11) s'étendant dans la direction longitudinale (x) de celui-ci ; une aiguille (20) qui est insérée dans un organe dans un corps, l'aiguille (20) étant constituée d'un matériau conducteur et disposée dans la cavité interne (11) du tube en résine (10) d'une manière mobile par rapport au tube de résine (10) dans la direction longitudinale (x) du tube en résine (10) ; une première électrode (31) disposée sur la surface externe (14) du tube en résine (10) ; et un instrument de mesure (40) qui mesure la résistance électrique qui se produit entre l'aiguille (20) et la première électrode (31) lorsqu'un courant électrique est appliqué entre l'aiguille (20) et la première électrode (31).
PCT/JP2023/037139 2022-10-27 2023-10-13 Système d'aiguille WO2024090235A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2022-172403 2022-10-27
JP2022172403 2022-10-27

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WO2024090235A1 true WO2024090235A1 (fr) 2024-05-02

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WO (1) WO2024090235A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2004290583A (ja) * 2003-03-28 2004-10-21 Terumo Corp 穿刺センサを有するカテーテル
JP2004290582A (ja) * 2003-03-28 2004-10-21 Terumo Corp 穿刺センサを有するカテーテル
JP2007020628A (ja) * 2005-07-12 2007-02-01 Terumo Corp カテーテルおよび医療装置
JP2019154926A (ja) * 2018-03-15 2019-09-19 テルモ株式会社 医療器具及び穿刺状態判定方法

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2004290583A (ja) * 2003-03-28 2004-10-21 Terumo Corp 穿刺センサを有するカテーテル
JP2004290582A (ja) * 2003-03-28 2004-10-21 Terumo Corp 穿刺センサを有するカテーテル
JP2007020628A (ja) * 2005-07-12 2007-02-01 Terumo Corp カテーテルおよび医療装置
JP2019154926A (ja) * 2018-03-15 2019-09-19 テルモ株式会社 医療器具及び穿刺状態判定方法

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